Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is inviting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. These comments will be considered in preparing a response from the United States to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drug substances. This notice requesting comments is required by the Controlled Substances Act (CSA).

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Exposures, Health Effects, and Controls of Chemicals from Thermal Spray Coating. The purpose of the proposed data collection is to conduct a survey of thermal spray coating facilities to better understand work practices and controls related to metals, particles, and gases generated during thermal spray coating and to identify areas for potential intervention.

The Food and Drug Administration (FDA or Agency) has determined that CUBICIN (daptomycin) Powder for Injection, 250 milligrams (mg)/vial and 500 mg/vial, and CUBICIN RF (daptomycin) Powder for Injection, 500 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for daptomycin powder for injection, 250 mg/vial and 500 mg/vial, if all other legal and regulatory requirements are met.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on revisions to an approved information collection. The request consists of several forms that allow the Unaccompanied Children (UC) Program to process release of unaccompanied children from ORR custody and provide services after release.

This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Confederated Tribes of Grand Ronde (CTGR) in the State of Oregon to include the county of Clackamas in the State of Oregon. The current PRCDA for the CTGR includes the Oregon counties of Washington, Polk, Yamhill, Marion, Multnomah, and Tillamook. The CTGR members residing outside of the PRCDA are eligible for direct care services, however, they are not eligible for Purchased/Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional CTGR members and beneficiaries to receive PRC services.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the forms Medical Assessment Form (formerly, the Initial Medical Exam (IME) Form and Supplemental Tuberculosis (TB) Screening Form) and Dental Assessment Form (formerly, the Dental Exam Form) (Office of Management and Budget (OMB) #0970- 0466, expiration December 31, 2023). Changes are proposed to the currently approved forms.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Waivers, Exceptions, and Exemptions from the Requirements of section 582 of the Federal Food, Drug, and Cosmetic Act.'' This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the factors FDA intends to consider when evaluating such requests from an authorized trading partner or other stakeholder, and when determining FDA-initiated exceptions and exemptions. Additionally, this guidance describes the process the FDA intends to follow once every 2 years to review and make determinations on the appropriateness of renewing a previously approved waiver, exception, or exemption, where applicable. This guidance finalizes the draft guidance of the same title issued on May 9, 2018.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VERCISE DEEP BRAIN STIMULATION SYSTEM (VERCISE DBS SYSTEM) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DELSTRIGO, new drug application (NDA) 210807, and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a 3-year extension to the Ongoing Progress Report (OPR) and the Objective Work Plan (OWP) (Office of Management and Budget (OMB) #0970-0452, expiration September 30, 2023). There are no changes requested to the forms.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Raidel Figueroa from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Figueroa was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Figueroa was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why he should not be debarred within the timeframe prescribed by regulation. Mr. Figueroa has not responded to the notice. Mr. Figueroa's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) has determined that K-TAB (potassium chloride) extended-release tablets, 10 milliequivalents and 20 milliequivalents, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for potassium chloride extended-release tablets, 10 milliequivalents (meqs) and 20 meqs, if all other legal and regulatory requirements are met.

This document proposes amendments to regulations implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and proposes new regulations implementing the nonquantitative treatment limitation (NQTL) comparative analyses requirements under MHPAEA, as amended by the Consolidated Appropriations Act, 2021 (CAA, 2021). Specifically, these proposed rules would amend the existing NQTL standard to prevent plans and issuers from using NQTLs to place greater limits on access to mental health and substance use disorder benefits as compared to medical/ surgical benefits. As part of these changes, these proposed rules would require plans and issuers to collect and evaluate relevant data in a manner reasonably designed to assess the impact of NQTLs on access to mental health and substance use disorder benefits and medical/surgical benefits, and would set forth a special rule with regard to network composition. These proposed rules would also amend existing examples and add new examples on the application of the rules for NQTLs to clarify and illustrate the protections of MHPAEA. Additionally, these proposed rules would set forth the content requirements for NQTL comparative analyses and specify how plans and issuers must make these comparative analyses available to the Department of the Treasury (Treasury), the Department of Labor (DOL), and the Department of Health and Human Services (HHS) (collectively, the Departments), as well as to an applicable State authority, and participants, beneficiaries, and enrollees. The Departments also solicit comments on whether there are ways to improve the coverage of mental health and substance use disorder benefits through other provisions of Federal law. Finally, HHS proposes regulatory amendments to implement the sunset provision for self-funded, non-Federal governmental plan elections to opt out of compliance with MHPAEA, as adopted in the Consolidated Appropriations Act, 2023 (CAA, 2023).

This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. Additionally, this final rule rebases and revises the IPF market basket to reflect a 2021 base year. These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2023 through September 30, 2024 (FY 2024). In addition, this final rule discusses quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program with changes beginning with the FY 2025 payment determination through changes beginning with the FY 2028 payment determination.

Notice is hereby given for the meeting on August 29, 2023, of the Center for Substance Abuse Prevention National Advisory Council (CSAP NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/ advisory-councils/meetings . The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of April 25, 2023; planned CSAP activities and programming for Fiscal Year 2024; presentations on substance use prevention priorities; Council discussion and public comments.

The Administration for Children and Families (ACF), is requesting a 3-year extension of the information collection Case Plan Requirement, Title IV-E of the Social Security Act, (Office of Management and Budget (OMB) #0970-0428, expiration September 30, 2023). There are no changes to the requirements, but burden estimates have been updated to reflect current numbers of children in foster care.

This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Interested individuals may attend the meeting in person or view the meeting webcast. Registration is required to attend in person and/or present oral comments. Written public comments will be accepted. Information about the meeting and registration are available at https:// ntp.niehs.nih.gov/go/32822.

The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 059'' (Recognition List Number: 059), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedure by which a manufacturer or distributor of a new dietary ingredient or of a dietary supplement containing a new dietary ingredient is to submit to FDA information upon which it has based its conclusion that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe.

Statement of Organization, Functions, and Delegations of Authority Part A, Office of the Secretary, Statement of Organization, Function, and Delegation of Authority for the U.S. Department of Health and Human Services (HHS) is being amended at Chapter AC, Office of the Assistant Secretary for Health (OASH), as last amended June 1, 2022. This notice establishes the Office of Long COVID Research and Practice in OASH.

The Centers for Medicare and Medicaid Services, Center for Medicare and Medicaid Innovation (CMMI), has modified its organizational structure.

This document corrects a technical error that appeared in the final rule published in the Federal Register on April 12, 2023 titled ``Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly.''

This Notice advises the public that the Indian Health Service (IHS) proposes to view the seven Mid-Atlantic Tribes in the Commonwealth of Virginia collectively and to expand the geographic boundaries of their current Purchased/Referred Care Delivery Areas (PRCDA). The seven Mid-Atlantic Tribes include the Pamunkey Indian Tribe, Chickahominy Indian Tribe, Chickahominy Indian TribeEastern Division, Upper Mattaponi Tribe, Rappahannock Tribe, Monacan Indian Nation, and Nansemond Indian Tribe. The IHS previously designated a PRCDA for each of the seven Tribes, which include counties and/or independent cities in the Commonwealth of Virginia. The IHS is now proposing to expand those individual PRCDAs by creating a collective PRCDA for the seven Tribes. The collective PRCDA will include all of the counties and independent cities in each of the current PRCDAs, plus additional contiguous counties and independent cities in the Commonwealth of Virginia, the State of Maryland, and the State of North Carolina.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Health Hazard Evaluations/Technical Assistance and Emerging Problems. This data collection is designed to assist the National Institute for Occupational Safety and Health (NIOSH) in responding to requests for Health Hazard Evaluations (HHEs) to identify chemical, biological or physical hazards in workplaces throughout the United States.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with product jurisdiction and combination product regulations.

This notice announces the second public meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee on August 16, 2023. The GAPB Advisory Committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Departments of Labor, Health and Human Services, and the Treasury (the Departments) and relevant States, and the prevention of balance billing to consumers. The recommendations will address options, best practices, and identified standards to prevent instances of balance billing; steps that can be taken by State legislatures, State insurance regulators, State attorneys general, and other State officials as appropriate, consistent with current legal authorities regarding consumer protection; and, legislative options for Congress to prevent balance billing.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these systems. In this proposed rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. This proposed rule also would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We also propose to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). We propose to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. We also seek comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, we propose to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, we propose a technical correction to the Rural Emergency Hospital Conditions of Participation.

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is partially open to the public.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director Data and Surveillance Workgroup (DSW). The DSW consists of approximately 15 members who are experts in fields associated with public health science and practice; policy development, analysis, and implementation; and surveillance and informatics.

Notice is hereby given of the combined (joint) meeting on August 30, 2023, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2024 rates for the small business establishment fee ($6,196), the non-small business establishment fee ($20,036), and the reinspection fee ($18,588) for outsourcing facilities; provides information on how the fees for FY 2024 were determined; and describes the payment procedures outsourcing facilities should follow.

The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2024, which apply from October 1, 2023, through September 30, 2024, and provides information on how the fees for FY 2024 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

HHS exempts certain records in an existing system of records maintained by OCSE within ACF from the accounting, access, and amendment requirements of the Privacy Act. The affected system of records is OCSE Federal Case Registry of Child Support Orders, HHS/ACF/ OCSE, System No. 09-80-0385. Only case files marked with the Family Violence Indicator (FVI) will be exempted, to align with a restriction in section 453(b)(2) of the Social Security Act which prohibits disclosure of case files marked with the FVI to anyone other than a court or agent of a court, to avoid harm to the custodial parent or the child of such parent.

The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2024 rates for GDUFA III fees. These fees are effective on October 1, 2023, and will remain in effect through September 30, 2024.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials Application,'' OMB Control Number 0917-0009, which expires August 31, 2023.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Office of Child Care invites public comment on the rules and regulations of the Tribally administered Child Care and Development Fund (CCDF) program as part of the Administration for Children and Families' (ACF) commitment to creating partnerships with Tribal Nations to identify and implement solutions that transcend traditional program boundaries. As part of that commitment, OCC seeks input on the requirements, regulations, and processes for Tribal Nations that administer CCDF. This Request for Information (RFI) specifically seeks public comment on the following topics of the Tribal child care programCCDF Funding Policies for Tribes, CCDF Administration, Improving Families' Access to Child Care, and Increasing Child Care Supply in Tribal Communitiesbut input on any aspect of the Tribally administered CCDF program is welcome. OCC will host a Tribal consultation during the RFI public comment period.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. On September 27, 2023, the committee will discuss and make recommendations on biologics license application (BLA) 125782 from BrainStorm Therapeutics, Inc. for debamestrocel (autologous bone marrow-derived mesenchymal stromal cells induced to secrete neurotrophic factors). The applicant has requested an indication for the treatment of amyotrophic lateral sclerosis (ALS). The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

ACF, ORR, Division of Refugee Health (DRH) announces the intent to award supplements in the aggregate amount of up to $466,563 to nine grant recipients under Notice of Funding Opportunity: Direct Services for Survivors of Torture, HHS-2022-ACF-ORR-ZT-0051. The purpose of the awards is to ensure that the 222 Nicaraguan Humanitarian Parolees (NHP) who were brought to the United States will have access to holistic care and services. This supplement will enable the identified grant recipients in California, Florida, Georgia, Maryland, Minnesota, Texas, and Virginia to provide access to medical, mental health, social, and legal services to NHP within their geographic service areas, and coordinate with The Center for Victims of Torture in Minnesota and other providers to serve NHP outside their service areas. The goal of these services is to help the NHP improve their health, find employment and stable housing, and regularize their immigration status.

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data on programs serving youth transitioning out of foster care as part of the Chafee Strengthening Outcomes for Transition to Adulthood Project. The generic mechanism will allow ACF to conduct rapid-cycle evaluations that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The purpose of these data collections submitted under the generic will be to inform ACF programming by building the evidence about what works to improve outcomes for the target population and to identify innovative learning methods that address common evaluation challenges.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk'' (M7(R2) Guidance) and two supplemental documents entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes'' (M7(R2) Addendum) and ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers'' (M7(R2) Questions and Answers). The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance and supplemental documents are intended to harmonize the considerations for assessment and control of DNA reactive (mutagenic) impurities. The M7(R2) Guidance and M7(R2) Addendum replace the guidance for industry entitled ``M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk,'' issued on March 14, 2018. The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers, also finalize the draft guidances for industry entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes'' and ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk Questions and Answers'' issued on April 7, 2022, and September 29, 2020, respectively.

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods,'' published in the Federal Register of June 15, 2023, to allow interested parties additional time to submit comments. We are taking this action due to technical difficulties experienced on the final two days of the comment period that may have prevented some interested parties from submitting comments.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual listening session entitled ``Public Meeting and Listening Session for Developing FDA's Center for Tobacco Products' Strategic Plan.'' The purpose of the listening session is to obtain feedback on the proposed strategic goals that are being used to develop FDA's Center for Tobacco Products' (CTP) comprehensive Strategic Plan. FDA will provide information on the proposed goals and provide the public an opportunity to provide open public comment.

The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation (OPRE) at the U.S. Department of Health and Human Services is proposing to collect information to examine a promising strategy to support the child care and early education (CCEE) workforce in Colorado as part of the Building and Sustaining the CCEE Workforce BASE project. This project aims to build evidence about workforce development strategies designed to promote, retain, and advance the CCEE workforce by improving the economic well- being of CCEE workers.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Elgia Therapeutics Inc. (``Elgia''), headquartered in La Jolla, CA.

The Department of Health and Human Services (HHS) is seeking public comment on its draft Scientific Integrity Policy through the Department of Health and Human Services website at https://www.hhs.gov/ programs/research/scientificintegrity.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This notice announces the dates and times of a virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) in August of 2023. In addition, it announces 8 new membership appointments to the Panel. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center payment system; and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as we prepare the annual update for the OPPS.

The Departments of Health and Human Services and Agriculture announce the third meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually. Additionally, this notice informs the public of the opportunity to provide oral comments virtually to the Committee regarding its work.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data from grantee agencies participating in the Voluntary Agencies Matching Grant Program. Client data collected will include enrollment information, demographics, and program outcomes.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections (``Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections''). The Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections updates the Guideline for infection control in health care personnel, 1998 (``1998 Guideline''), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and its corresponding recommendations in Part II of the 1998 Guideline: ``8. Measles;'' ``10. Mumps;'' ``15. Rubella;'' and ``21. Varicella.'' The updated recommendations in the Draft Guideline: Measles, Mumps, Rubella, and Varicella-Zoster Virus Sections are intended for use by the leaders and staff of healthcare facilities and systems' Occupational Health Services (OHS), as further provided herein. These updated recommendations will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.

This notice acknowledges the receipt of an application from The Joint Commission (TJC) for continued recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-576 and CMS-576A] entitled ``Organ Procurement Organization (OPO) Request for Designation as an OPO, Health Insurance Benefits Agreement, and Supporting Regulations'' that was published in the June 13, 2023 Federal Register. The comment period for the information collection request, which would have ended on August 14, 2023, is extended to August 28, 2023.

The Indian Health Service (IHS or Service) administers the Catastrophic Health Emergency Fund (CHEF) pursuant to section 202 of the Indian Health Care Improvement Act (IHCIA). The purpose of the CHEF is to meet the extraordinary medical costs associated with the treatment of victims of disasters or catastrophic illnesses who are within the responsibility of the Service. This notice proposes regulations governing the administration of the CHEF.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.''

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ELEVIDYS (delandistrogene moxeparvovec-rokl), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry.'' The management of manufacturing changes presents many challenges for human cellular therapy or gene therapy (CGT) products due to the complexity of these products. The draft guidance provides sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products, with recommendations regarding product comparability and the management of manufacturing changes for investigational and licensed CGT products. The purpose of this draft guidance is to provide FDA's current thinking on management and reporting of manufacturing changes for CGT products based on a life-cycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.